Looking For Vikril (Polyglactin 910)

RFQ Description

We are looking for manufacturer (preferably from India/Malasiya/China) to arrange supplies of suture Vikril (Polyglactin 910) 0.75 m- 1.5 m with needles (1/2 - 5/8) diameter 17-25 mm. The key requirement is the willingness and ability to arrange the whole set of documents for importation: 10. For the state registration of a medical device in the Russian Federation, the following documents are submitted: a) a copy of the document confirming the powers of the authorized representative of the manufacturer (manufacturer); b) information about the regulatory documentation for the medical device; c) technical documentation of the manufacturer (manufacturer) for a medical device; d) operational documentation of the manufacturer (manufacturer) for a medical device, including instructions for use or operating instructions for a medical device; e) photographic images of the general appearance of the medical device together with the accessories necessary for the intended use of the medical device (size not less than 18 x 24 centimeters); f) documents confirming the results of technical tests of a medical device; g) documents confirming the results of toxicological studies of a medical device, the use of which implies contact with the human body; h) documents confirming the results of tests of a medical device for the purpose of approving the type of measuring instruments (in relation to medical devices related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation); i) an inventory of documents; j) for medical devices of the 1st class of potential risk of use and medical devices for in vitro diagnostics - information confirming the clinical efficacy and safety of medical devices; k) a draft clinical trial plan for a medical device with supporting materials (if available); m) information on permits issued by the registering authority for the import of medical devices for the purpose of their state registration (for foreign-made medical devices); h) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substances with which the medical device was manufactured or which are part of it and which are intended for use only taking into account the purpose of the medical device determined by the manufacturer and issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material and other substances.